New Insomnia Drug Shows Promise

June 25, 2005

In trial, ramelteon helped users doze off and sleep longer

HealthDay News — The investigational drug ramelteon reduced the time it took for people with chronic insomnia to fall asleep and also increased their total sleep time, according to the results of a Phase III study sponsored by the drug’s maker, Takeda Pharmaceuticals.

The study also found no evidence of rebound insomnia, next-day impairments or withdrawal effects after people stopped using the drug. The U.S. Food and Drug Administration is currently reviewing ramelteon for treatment of insomnia.

The study included 405 adults with chronic insomnia who, for 35 nights, received either 8 mg or 16 mg of ramelteon, or a placebo before they went to bed. For four of those nights, the study participants were monitored in a sleep center. On all other nights of the study, the participants slept at home.

The findings were presented this week at the recent annual meeting of the Associated Professional Sleep Societies in Denver.

More than 20 million Americans have complaints of chronic insomnia, according to the American Insomnia Association.

“Probably more than half of all Americans experience a sleep problem at some time in their lives, and it’s a serious problem for many adults,” Gary Zammit, director of the Sleep Disorders Institute, St. Luke’s-Roosevelt Hospital, New York, said in a prepared statement.

“People with insomnia often complain of impairments in intellectual abilities like attention, memory or concentration, impairments in their mood, feeling depressed or irritable or anxious, and impairment in their ability to function in the workplace, at home or even at school,” Zammit said.

More information:

The American Academy of Family Physicians has more about insomnia (familydoctor.org ).